MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERJECT; BIOPSY NEEDLE KIT

Model Number	M00518301
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was used in the stomach during a tissue resection procedure performed on (b)(6) 2021.During the procedure, the needle was halved.The procedure was completed with another interject needle.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0501 capture the reportable event of needle detached.Block h10: investigation results: the interject needle was returned for analysis.A visual inspection was performed and it was noted the needle was in the retracted position when received.The needle was not broken, it was properly attached to the device.The working length was kinked approximately at 83.5cm from the outer hub.A functional inspection was performed which noted the device would extend and retract without issue.The handle operation was smooth when actuating the device.No other issues were noted.The complaint was not confirmed.Based on all available information and the condition of the returned device, it is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Handling and manipulation of the device during procedure could have kinked the working length.Also, interaction with the scope while the device is being advanced through it could have kinked the device.Therefore, the most probable root cause for the failure found during analysis is adverse event related to procedure.However, the reported failure of needle detachment was not confirmed during the analysis.Therefore, the root cause for the reported failure is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was used in the stomach during a tissue resection procedure performed on (b)(6) 2021.During the procedure, the needle was halved.The procedure was completed with another interject needle.There were no patient complications reported as a result of this event.

• Brand Name: INTERJECT
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12112096
• Report Number: 3005099803-2021-03095
• Device Sequence Number: 4203154
• Product Code: FCG
• UDI-Device Identifier: 08714729296508
• UDI-Public: 08714729296508
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K171454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2024
• Device Model Number: M00518301
• Device Catalogue Number: 1830
• Device Lot Number: 0027100471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1